Remove 2017 Remove Clinical Pharmacology Remove Pharmacokinetics
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Vamorolone

New Drug Approvals

2017, 82, 11961−11980. (77) 2017, 82,11961−11980. 12] History In phase I clinical trials of adult volunteers, vamorolone was shown to be safe and well tolerated, with blood biomarker data suggesting possible loss of safety concerns of the corticosteroid class. [13] Archived from the original on 7 October 2017. McCall, J.

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Landiolol

New Drug Approvals

Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics. Dean L (2017). July 2017). PMID 27092187. Atarashi H, Kuruma A, Yashima M, Saitoh H, Ino T, Endoh Y, et al. August 2000). 68 (2): 14350.

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ATICAPRANT

New Drug Approvals

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

In 2017, the FDA expanded the restrictions , which include behind-the-counter sale requiring photo identification with a per-month individual purchase quota, to products containing ephedrine and phenylpropanolamine — effectively narrowing the decongestant drugs approved for over-the-counter sale.

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Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.”

Science 40
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Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

Oncology at FDA in 2023: A quick glance at the numbers First created under the 21st Century Cures Act of 2016 and launched in 2017, FDA’s Oncology Center of Excellence (OCE ) “unites experts across the FDA to conduct expedited review of medical products for oncologic and hematologic malignancies.”

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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